510(k) · Cleared
ClearediFuse Implant System- iFuse Navigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SI-BONE, Inc. · OLO Orthopedic Stereotaxic Instrument
Cleared on Oct 31, 2017 as substantially equivalent to K131405 (SI-BONE, Inc., 2013) and 1 other predicate after a 96-day review. Its family tree reaches back 13 generations to 1993. 46 later devices descend from it.
- Decided
- Oct 31, 2017
- Review
- 96 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K930834 (1993). 29 ancestors in all, the oldest K903810 (1990). 46 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK930834 AcutractAcu Med, Inc. · 1993
- 9 generations between
- 3 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 2 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 1 generation backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- This deviceK172268 iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017
- Descendant · cites it directly · 32 of its ownK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
- Descendant · 2 generations on · 20 of its ownK222774 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022
- Descendant · cites it directly · 14 of its ownK222605 iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 3 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · 3 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK930834 AcutractAcu Med, Inc. · 1993
- 12 generations backK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
- 11 generations backK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
- 10 generations backK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
- 9 generations backK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
- 8 generations backK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 7 generations backK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013
- 6 generations backK141049 Ifuse Implant SystemSI-BONE, Inc. · 2014
- 5 generations backK150714 SI-BONE iFuse Implant SystemSI-BONE, Inc. · 2015
- 4 generations backK151718 iFuse Implant SystemSI-BONE, Inc. · 2015
- 3 generations backK152681 iFuse Implant System (R)SI-BONE, Inc. · 2016
- 2 generations backK160652 iFUSE Implant SystemSI-BONE, Inc. · 2016
- 1 generation backK162733 iFuse Implant System® - iFuse-3D implantSI-BONE, Inc. · 2017
- This deviceK172268 iFuse Implant System- iFuse NavigationSI-BONE, Inc. · 2017
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022 · cites it directly32descendants
- K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022 · 2 generations on20descendants
- K222605iFuse TORQ® Implant SystemSI-BONE, Inc. · 2022 · cites it directly14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 3 generations on11descendants
- K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K930834 | Acutract | Acu Med, Inc. | 1993 | — |
| −12 | K051309 | Roi Fusion Rods & Plates | Reiley Orthopaedics, Inc. | 2005 | 2 |
| −11 | K080398 | SI Joint Fusion System | SI-BONE, Inc. | 2008 | — |
| −10 | K110838 | Ifuse Implant System | SI-BONE, Inc. | 2011 | — |
| −9 | K122074 | Ifuse Implant System | SI-BONE, Inc. | 2012 | — |
| −8 | K123850 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −7 | K131405 | Ifuse Implant System | SI-BONE, Inc. | 2013 | — |
| −6 | K141049 | Ifuse Implant System | SI-BONE, Inc. | 2014 | — |
| −5 | K150714 | SI-BONE iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −4 | K151718 | iFuse Implant System | SI-BONE, Inc. | 2015 | — |
| −3 | K152681 | iFuse Implant System (R) | SI-BONE, Inc. | 2016 | — |
| −2 | K160652 | iFUSE Implant System | SI-BONE, Inc. | 2016 | — |
| −1 | K162733 | iFuse Implant System® - iFuse-3D implant | SI-BONE, Inc. | 2017 | — |
| 0 (this device) | K172268 | iFuse Implant System- iFuse Navigation | SI-BONE, Inc. | 2017 | — |
| +1 | K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022 | — |
| +2 | K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022 | — |
| +1 | K222605 | iFuse TORQ® Implant System | SI-BONE, Inc. | 2022 | — |
| +3 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +3 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 8 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131405 | Ifuse Implant SystemSummary page 4…t Product Codes: OLO; Stereotaxic Instrument III. PREDICATE DEVICES Primary Predicate: iFuse Implant System by SI-BONE: K131405, K162733 Reference Predicates: -K161210, Medtronic Reusable Instruments Compatible… | 2013 |
| * | K162733 | iFuse Implant System® - iFuse-3D implantSummary page 4…Product Codes: OLO; Stereotaxic Instrument III. PREDICATE DEVICES Primary Predicate: iFuse Implant System by SI-BONE: K131405, K162733 Reference Predicates: -K161210, Medtronic Reusable Instruments Compatible… | 2017 |
| † | K161210 | RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)… | 2016 |
| † | K150216 | Synergy Cranial | 2015 |
| † | K162921 | Navigated Instrument System | 2017 |
What descends from it? (46)
See all 465 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 29 ancestors have a recall of any class.
- Of its descendants, K220195 (SI-BONE, Inc., 2022) has gone furthest, with 32 descendants of its own.
- 9 other devices also cite its predicate K131405.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
iFuse-Navigation instruments are intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172268 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172268: iFuse Implant System- iFuse Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172268
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026